US6847847B2 - Retina implant assembly and methods for manufacturing the same - Google Patents
Retina implant assembly and methods for manufacturing the same Download PDFInfo
- Publication number
- US6847847B2 US6847847B2 US10/011,641 US1164101A US6847847B2 US 6847847 B2 US6847847 B2 US 6847847B2 US 1164101 A US1164101 A US 1164101A US 6847847 B2 US6847847 B2 US 6847847B2
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- United States
- Prior art keywords
- chip
- retina
- receiver coil
- eye
- implant
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- Expired - Lifetime, expires
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/14—Eye parts, e.g. lenses, corneal implants; Implanting instruments specially adapted therefor; Artificial eyes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F9/00—Methods or devices for treatment of the eyes; Devices for putting-in contact lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
- A61F9/08—Devices or methods enabling eye-patients to replace direct visual perception by another kind of perception
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/02—Details
- A61N1/04—Electrodes
- A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
- A61N1/0526—Head electrodes
- A61N1/0543—Retinal electrodes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/372—Arrangements in connection with the implantation of stimulators
- A61N1/378—Electrical supply
- A61N1/3787—Electrical supply from an external energy source
Definitions
- the invention relates to a retina implant having a chip for subretinal implantation, and comprising a receiver coil for inductively coupling thereinto electromagnetic energy, the coil being connected to means for converting an alternating voltage induced into the receiver coil into a direct voltage suited for supplying the chip.
- the invention is related to a method for manufacturing a retina implant as specified before.
- Implants of that kind are generally known.
- a light-sensitive chip shall be implanted into the subretinal space below the retina.
- the chip is provided with a plurality of pixel elements receiving an image projected on the retina through the still intact lens of the eye, for converting same into electrical signals and for further converting same into electrical stimuli via a plurality of stimulation electrodes to stimulate the retinal cells adjacent the chip, in order to reconstruct or improve vision of blind or partially blind patients.
- U.S. Pat. No. 4,628,933 discloses a retina implant which, however, is not intended to be used for subretinal implantation but for epiretinal implantation instead, i.e. the light-sensitive chip shall not be implanted into the subretinal space but directly onto the surface of the retina.
- the stimulation electrodes therefore, are not provided on the side of the chip facing the lens but on its rear side instead.
- U.S. Pat. No. 4,628,933 suggests to transmit energy to the implant via electromagnetic induction.
- a receiver coil is wound around the periphery of the implant chip.
- radiofrequency energy having been transmitted from an external source of energy which, for example, may be located in an eyeglass frame, is received and is transformed into electrical energy for supplying the chip.
- subretinal implants have been developed recently which have not been supplied via rf coupling of electromagnetic energy but via invisible infrared radiation which was converted into electrical energy by means of an appropriate photovoltaic layer.
- a subretinal implant of the type specified before is disclosed e.g. in WO 98/17343.
- an object underlying the invention to provide an improved retina implant being supplied with electromagnetic energy via inductive coupling and which may be implanted into the subretinal space simply and without the risks of complications.
- this object is achieved in that the receiver coil is configured to be received and positioned on the eyeball outside the sclera.
- the receiver coil As the receiver coil is affixed to the sclera outside the eye, the chip that has to be implanted into the subretinal space may be dimensioned appropriately which is of particular advantage for an implantation into the subretinal space. In contrast, the receiver coil may be provided with a sufficiently large cross-section and a sufficiently high number of windings without incurring disadvantageous effects.
- the receiver coil, the chip as well as connecting leads leading to the chip are housed within a flat plastic material body.
- the converting means is configured as a unit separate from the chip, the unit being adapted to be positioned on the eyeball outside the sclera.
- the portion of the entire retina implant to be implanted into the subretinal space is made still smaller because the converter means must be provided with a rectifier and with smoothing capacitors which require a certain space and, hence, may not be directly combined with the chip without substantially increasing the dimensions thereof.
- That portion of the implant to be implanted into the subretinal space of the eyeball is made still smaller so that that portion of the plastic material body may be configured as a thin foil and the chip may be integrated into a terminal end thereof.
- the plastic material body comprises an annular portion having a central opening, the annular portion being adjoined by a flat extension.
- the receiver coil may be integrated into the annular portion of the plastic material body in a most suitable manner, whereas the chip may be provided at the end of the flat extension.
- the annular portion is dimensioned as to enclose the lateral straight eye muscle rudiment.
- This measure has the advantage that a particularly preferable arrangement and positioning of the receiver coil on the eye is achieved.
- the eye muscle must be severed, however, may thereafter be sewed together again which, in view of modern surgical techniques, does not present a problem at all.
- the excitation coils for the energy supply may be arranged in the area of the temples, for example on an eyeglass frame.
- the converting means is comprised within the plastic material body in a position adjacent the receiver coil.
- the receiver coil comprises windings integrated into the annular portion and being, preferably, configured in a spiralled pattern.
- the receiver coil may advantageously be integrated into the annular portion of the plastic material body.
- the annular portion is subdivided into a plurality of sections in a circumferential direction, the sections being separated from each other by gaps and being electrically and mechanically interconnected.
- This feature allows to improve the flexibility of the annular portion so that the annular portion of the plastic material body may perfectly be applied to the bulged surface of the eye even if it consists of a material of relatively high tensile strength.
- the sections may be interconnected with each other by a fin in a radial direction, or the sections may be made to adhere each other in a spiralled configuration.
- the individual sections each have a plurality of windings and are interconnected in a radial direction via fins which also carry the electrical connections between neighbored windings.
- the annular portion may first be manufactured as a planar body and may subsequently be brought into the desired bulged shape.
- annular portion of the plastic material body may have a meander shape in order to obtain an improved flexibility.
- strain relief means are provided at least between the converter means and a connection lead leading to the chip or to the receiver coil.
- the strain relief means may, for example, be obtained by a meander-shaped configuration substantially in the area between the annular portion and the flat extension where the converter means is received or in an area immediately adjacent the converter means.
- the electrical interconnection between the receiver coil, the converter means and the chip are protected against hazardous influences which may result from the continuous movement of the eyeball, so that even years after an implantation a reliable voltage supply for the implanted chips is guaranteed.
- the receiver coil has a number of windings of about between 50 and 200, preferably about 100 windings.
- a receiver coil of that kind may be operated in combination with an external transmitter coil at a frequency of 1 MHz, when the transmitter coil has about 1000 windings with a diameter of about 50 mm and is attached to, for example, an eyeglass frame.
- the receiver coil has an outer diameter of about between 12 and 20 mm and an inner diameter at the opening of about between 8 and 16 mm.
- the flat extension is provided with a plurality of perforations.
- perforations may be arranged along an array of about between 0.1 and 1 mm width and have a diameter in the area of about between 20 and 200 ⁇ m.
- the chip is embedded in the flat extension, the active side of the chip lying open at the surface for stimulating cells.
- the flat plastic material body is provided with lugs for affixing the plastic material body to the eyeball.
- the lugs may either be provided at the annular portion as well as in the flat extension, preferably in the area where the converter means are received.
- the converter means comprises means for processing an information signal transmitted together with the electromagnetic energy, in particular for processing a referenced signal indicative for ambient light intensity or brightness.
- the flat plastic material body is generated on an auxiliary substrate and may be separated therefrom thereafter.
- the strip conductors are preferably generated on the surface by means of thin film methods (vapor deposition or sputtering) and are then microstructured photolithographically.
- the object underlying the invention is, further, achieved by a method for manufacturing a retina implant having a chip for subretinal implantation, and comprising a receiver coil for inductively coupling thereinto electromagnetic energy, means for converting an alternating voltage induced into the receiver coil into a direct voltage suited for supplying the chip, the method comprising the steps of:
- a retina implant accordingly, having a thin foil-type extension with the chip to be implanted, the retina implant being configured as an integral flat unit which may be implanted in a particularly advantageous manner and with a minimum of potential complication and which, further, has a long lifetime over a sufficiently long period of time.
- the converter means is affixed to the plastic material body by gluing, by bonding to the metallic strip conductors and/or by injection-molding same with a plastic material mass.
- the plastic material body is manufactured from polyimide, polymethylmetacrylate (PMMA) or epoxy resin. Likewise, these materials may be utilized for embedding the chip and/or for embedding the converter means by injection-molding.
- the plastic material body together with the isolation layer is manufactured with a thickness of about between 5 and 15 micrometers, preferably about 10 micrometers.
- the receiver coil as well as the chip and the necessary leads may be housed in a thin foil-type body which is well-suited for implantation purposes.
- the strip conductors have a thickness of about between 0.5 and 2 micrometers, preferably of about 1 micrometer.
- the strip connectors are preferably generated by vapor deposition or sputtering, respectively, allowing an advantageous manufacture.
- they consist of gold, titanium, platinum, iridium, aluminum, or copper.
- FIG. 1 shows a perspective view of a dissected eye with introduced retina implant
- FIG. 2 shows a view on the retina implant in a slightly modified embodiment, on an enlarged scale
- FIG. 3 is a cross-sectional view on the annular area of the implant along the line III—III on an enlarged scale;
- FIG. 4 shows the annular area of FIG. 3 when assuming a curved shape under a bending load
- FIG. 5 shows a portion of the annular area of the implant, on a still more enlarged scale as compared to FIG. 3 .
- FIG. 6 shows a schematic cross-sectional view through an eye with the introduced implant.
- FIGS. 1 and 6 an eyeball into which an implant according to the present invention shall be introduced, is designated as a whole by 10 .
- Eyeball 10 at its front side, has a cornea 11 and, further, a sclera 12 .
- the limbus corneae i.e. the rim of cornea 11 , is designated by 16 in FIG. 1 .
- FIG. 1 shows lateral eye muscles 14 and 15 .
- FIG. 1 shows that the retina implant was positioned around lateral eye muscle 13 with its annular portion 32 and was pushed into the subretinal space with its flat extension 33 through a sclera incision 20 .
- FIG. 2 shows the retina implant in a top plan view and on an enlarged scale.
- a strain relief is, further, provided, as will be explained hereinafter.
- Retina implant 30 comprises a receiver coil 37 for receiving electromagnetic energy (rf energy), irradiated thereinto, a converter means 35 , for rectifying and smoothening alternating current induced into receiver coil 37 and, as the case may be, stabilizing on a predetermined voltage, as well as the chip 36 for subretinal implantation.
- rf energy electromagnetic energy
- converter means 35 for rectifying and smoothening alternating current induced into receiver coil 37 and, as the case may be, stabilizing on a predetermined voltage, as well as the chip 36 for subretinal implantation.
- Converter means 35 which, due to the necessary smoothing capacitors, has a certain demand for space, is, therefore, configured as a unit separated spatially from chip 36 .
- Converter means 35 is positioned at the beginning of flat extension 33 adjacent annular area 32 .
- Converter means 35 consists, for example, of rectifiers, smoothing capacitors and rechargeable thin film batteries, respectively, and a voltage stabilizer. Moreover, it may comprise components for decoding and processing of information signals transmitted together with the electromagnetic energy, for example of reference signals indicative for ambient brightness.
- the retina implant comprises a flat plastic material body 31 consisting, preferably, of polyimide.
- Plastic material body 31 receives various components or these components are affixed thereto.
- a central opening or recess is provided within annular area 32 of plastic material body 31 .
- Central opening 34 has a diameter d 1 of about between 8 and 16 mm.
- the outer diameter d 2 of the annular portion is about between 12 and 20 mm.
- Receiver coil 37 is received within annular portion 32 .
- the windings thereof are indicated as an example at 38 in FIG. 2 .
- the ends of receiver 37 which, as may be taken from FIG. 2 , may comprise a zig-zag-shaped or meander-shaped tongue, are connected to converter means 35 .
- Converter means 35 is connected to chip 36 via connection leads 41 .
- Chip 36 is embedded into plastic material body 31 at the outer end of flat extension 33 . It goes without saying that its active surface which is supposed to stimulate cells, lies free.
- annular portion 32 and flat extension 33 are provided with lugs 49 and 50 , respectively.
- flat extension 33 in its portion being intended to be pushed into the subretinal space at a later point in time is provided with a plurality of perforations 52 .
- the perforations 52 are preferably arranged along an array of about between 0.1 and 1 mm width and have a diameter of about between 20 and 200 ⁇ m. By doing so, a diffusion of nutrients and oxygen between the pigment epithelium and the retina in enabled, thus avoiding negative effects that might result if the implant consisted of an impermeable material.
- Annular portion 33 receiving receiver coil 37 is preferably subdivided into a plurality of ring-shaped sections 51 in a circumferential direction, as may be seen from FIGS. 3 and 4 .
- Sections 51 are arranged coaxially one relative to the other, are separated by gaps 42 and are mechanically and electrically interconnected via radial fins 43 .
- Each of these sections 51 contains a plurality of windings 38 and has, for example, a width of the order of about 0.5 mm, whereas the entire width is of the order of between 3 and 4 mm.
- FIG. 3 shows an individual radial fin 43 between the two outer sections 51 .
- Radial fin 43 mechanically connects the two adjacent sections 51 and also allows the electrical connection between neighbored windings 38 .
- the connection to inner sections 51 is likewise effected through radial fins 43 which are preferably arranged at other positions of the annular portion in an angularly offset manner for obtaining a maximum flexibility of receiver coil 37 because plastic material body 31 , as will be explained hereinafter, is manufactured as a planar body which, however, shall be applied to the surface of the bulged eyeball without folds or wrinkles and, hence, consists of a plastic material.
- the isolated sections 51 into a spherical shape after the plastic material body has been fully manufactured, with the spherical shape corresponding to the bulge of the eyeball. It may, for example, be fixated in this bulged shape by molding with silicon, so that the manipulation is simplified during the subsequent implantation.
- the retina implant may, for example, be manufactured as follows:
- a thin plastic material layer 44 (see FIG. 5 ), that may consist, for example, of polyimide, PMMA or epoxy resin, is laminated or spun onto a planar auxiliary substrate 53 , for example a wafer of glass, silicon or ceramic.
- the auxiliary substrate 53 may, for example, also be a metal foil.
- metallic strip conductors 45 are generated on the surface of foil 44 .
- the metal for example gold, titanium, platinum, iridium, aluminum or copper, is vapor-deposited or sputtered onto the surface.
- all metallic strip conductors 45 i.e. the windings 38 of receiver coil 37 , the connections between the individual sections 51 of receiver coil 37 , the connection leads leading to the converter means 35 via strain relief 40 as well as connection leads 41 into connecting converter means 35 and chip 36 , which is finally effected by a subsequent photolithographic microstructuring.
- a bridge 39 extending from the inner end of receiver coil 37 to its outside must be connected separately.
- Chip 36 and converter means 35 are affixed to surface 47 of foil 44 , for example by conductive gluing or bonding.
- An isolating layer is deposited for entirely isolating strip conductors 45 .
- the isolating layer may consist of the same plastic material as the plastic material that had first been deposited on auxiliary substrate 53 , i.e. polyimide or PMMA.
- chip 36 and converter means 35 may be attached to the plastic material body 31 by conductive gluing or bonding after depositing isolation layer 46 onto foil 44 .
- the gaps 42 between neighbored sections 51 of receiver coil 47 and the meander-shaped strain relief 40 may also be generated in the course of the photolithographic microstructuring.
- perforations 52 within flat extension 33 are preferably generated by laser drilling.
- receiver coil 37 may, further, be molded with silicon to assume a spherical shape being adapted to the bulge to the bulge of an eyeball.
- Metallic strip conductors preferably, have a thickness of about between 0.5 and 2 micrometers, preferably of about 1 micrometer.
- receiver coil 37 together with foil 44 have a combined thickness y of about 10 micrometers.
- Retina implant 30 may be implanted as follows:
- a rein thread is applied and the eye is rolled to the inside.
- the conjunctiva is then shifted laterally, as a lobe as the case may be.
- a holding thread is applied to the muscle rudiment at the rudiment of the straight lateral eye muscle 13 and the muscle is then severed and flipped laterally together with the holding thread.
- a sclera incision 20 is then made into the sclera somewhat below the lateral eye muscle, either above or, as shown in FIG. 1 , slightly below eye muscle 13 .
- a small quadrangular lobe 21 is then cut in a wing shape and is flipped downwardly.
- Holding threads are now applied through the corners of lobe 21 and the lobe is then flipped rearwardly as shown in FIG. 1 .
- the choroid 22 below sclera 12 and the pigment epithelium are now opened along a slit (see FIG. 6 ) without perforating the retina 19 itself.
- the end of the extension 33 carrying chip 36 is now pushed into the choroid slit and advanced into the subretinal space, as the case may be under the control of a fiber optic, until about four fifth of the extension are within the eye 10 and the end thereof together with chip 36 have assumed their final position.
- the channel may be opened before with a flexible plastic material spatula similar to the extension of retina implant 30 by lifting retina 19 somewhat away from the pigment epithelium.
- the terminal end carrying chip 36 As soon as the terminal end carrying chip 36 has assumed its final position in the macula area, it is affixed in that position on the sclera by pulling two plastic material threads through the small perforated holes in the lugs 50 at extension 33 and by attaching same on the sclera with individual knots.
- the annular portion 32 together with receiver coil 37 is similarly attached by means of two more individual head seams drawn through perforations on the lugs 49 of the receiver coil 37 opposite extension 33 .
- Receiver coil 37 is positioned such that the root of lateral straight eye muscle 13 on its eyeball side is located within opening 34 of annular portion 32 .
- wing-shaped lobe 21 of sclera 11 is closed at its two corners with two further single head seams.
- the lateral straight eye muscle 13 is again pulled forwardly by means of the holding thread and is then attached to its original root over annular portion 32 by means of muscle seems.
- the conjunctiva is then again attached by means of a few single head seams and the rein thread is removed.
- an ointment dressing is applied.
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- Engineering & Computer Science (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Biomedical Technology (AREA)
- Ophthalmology & Optometry (AREA)
- Heart & Thoracic Surgery (AREA)
- Cardiology (AREA)
- Vascular Medicine (AREA)
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- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Transplantation (AREA)
- Prostheses (AREA)
Abstract
Description
-
- manufacturing a flat plastic material body having an annular portion with a central opening, the annular portion being adjoined by a flat extension,
- depositing metallic strip conductors on a surface of the annular portion in a spiralled configuration for making windings of the receiver coil and for creating connecting leads between the receiver coil, the converter means and the chip,
- affixing the chip and the converter means to the plastic material body,
- depositing an isolation layer over the metallic strip conductors.
Claims (49)
Applications Claiming Priority (5)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
DE19921398 | 1999-05-07 | ||
DE19931083A DE19931083C2 (en) | 1999-05-07 | 1999-07-06 | Retina implant and method of making one |
DE19931083.1 | 1999-07-06 | ||
DE19921398.4 | 1999-07-06 | ||
PCT/EP2000/003962 WO2000067676A1 (en) | 1999-05-07 | 2000-05-03 | Retina implant and method for producing the same |
Related Parent Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/EP2000/003962 Continuation-In-Part WO2000067676A1 (en) | 1999-05-07 | 2000-05-03 | Retina implant and method for producing the same |
Publications (2)
Publication Number | Publication Date |
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US20020198573A1 US20020198573A1 (en) | 2002-12-26 |
US6847847B2 true US6847847B2 (en) | 2005-01-25 |
Family
ID=26053289
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US10/011,641 Expired - Lifetime US6847847B2 (en) | 1999-05-07 | 2001-11-07 | Retina implant assembly and methods for manufacturing the same |
Country Status (4)
Country | Link |
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US (1) | US6847847B2 (en) |
EP (1) | EP1178763B1 (en) |
JP (1) | JP3599237B2 (en) |
WO (1) | WO2000067676A1 (en) |
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US20040054407A1 (en) * | 2002-08-30 | 2004-03-18 | Nidek Co., Ltd. | Artificial vision system |
US20050010266A1 (en) * | 2003-03-24 | 2005-01-13 | Les Bogdanowicz | Device and methodology for ocular stimulation |
US20050065602A1 (en) * | 2002-12-17 | 2005-03-24 | Visioncare Ophthalmic Technologies Inc. | Intraocular implants |
US20050222624A1 (en) * | 2004-04-06 | 2005-10-06 | Robert Greenberg | Retinal prosthesis with side mounted inductive coil |
US20060004446A1 (en) * | 2003-01-14 | 2006-01-05 | Visioncare Ophthalmic Technologies Inc. | Intraocular lens implant |
US20060069416A1 (en) * | 2003-01-31 | 2006-03-30 | Wilfried Nisch | Retina implant for stimulating a retina as a function of incident light |
US20060155374A1 (en) * | 2005-01-07 | 2006-07-13 | Visioncare Ophthalmic Technologies Inc. | Mirror implant |
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Also Published As
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WO2000067676A1 (en) | 2000-11-16 |
US20020198573A1 (en) | 2002-12-26 |
JP3599237B2 (en) | 2004-12-08 |
JP2002543878A (en) | 2002-12-24 |
EP1178763A1 (en) | 2002-02-13 |
EP1178763B1 (en) | 2008-12-10 |
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